Label: ALUMINUM HYDROXIDE liquid
- NDC Code(s): 0536-0091-85
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 15, 2017
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- Active ingredient (in each 5 mL teaspoonful)
- Other information
- Inactive ingredients
compare to the active ingredient in AMPHOJEL
Aluminum Hydroxide Gel, USP
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Rugby Laboratories, INC. is not affiliated with the owner of the trademark Amphojel.
16 fl oz (473 mL)
INGREDIENTS AND APPEARANCE
aluminum hydroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 320 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-0091-85 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/01/2005 Labeler - Rugby Laboratories (079246066) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP Laboratories 965480861 manufacture(0536-0091)